CDRH New Update

The following new items were added to the CDRH web pages on October 6, 2017 Previous CDRH New items can be found on the CDRH New webpage. Mammography Facility Adverse Event and Action Report - October 5, 2017: Jack County Hospital District dba Faith Community Hospital Meeting materials posted for October 11-12, 2017 Patient Engagement Advisory Committee Medical Device Approval: remedē® System - P160039 Press Release: FDA approves implantable device to treat moderate to severe central sleep apnea Federal Register: Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator; Correction